UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002701 |
|---|---|
| Receipt number | R000003291 |
| Scientific Title | Phase I study for immuno-hyperthermia against recurrent subcutaneous tumor using cationic magnetoliposome and alternative magnetic field irradiation |
| Date of disclosure of the study information | 2009/11/04 |
| Last modified on | 2013/11/05 22:28:49 |
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Basic information
Public title
Phase I study for immuno-hyperthermia against recurrent subcutaneous tumor using cationic magnetoliposome and alternative magnetic field irradiation
Acronym
Phase I study for immuno-hyperthermia against recurrent subcutaneous tumor using cationic magnetoliposome and alternative magnetic field irradiation
Scientific Title
Phase I study for immuno-hyperthermia against recurrent subcutaneous tumor using cationic magnetoliposome and alternative magnetic field irradiation
Scientific Title:Acronym
Phase I study for immuno-hyperthermia against recurrent subcutaneous tumor using cationic magnetoliposome and alternative magnetic field irradiation
Region
| Japan |
Condition
Condition
subcutaneous recurrent tumor (breast cancer, malignant head and neck tumor, malignant soft tissue tumor, malignant oral cavity tumor)
Classification by specialty
| Breast surgery | Oto-rhino-laryngology | Orthopedics |
| Oral surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This clinical trial is phase I trial to establish immune-hyperthermia using cationic magnetoliposome and alternative magnetic field irradiation as a new modality for refractory subcutaneous tumor. The safety of this immune-hyperthermia will be evaluated for the patients with measurable subcutaneous recurrent tumor which is diagnosed histologically or cytologically. The effectiveness of this modality will be also evaluated.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
Dose limiting toxicity and other adverse events
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
cationic magnetoliposome
level I: 5mg/body
level II: 50mg/body
level III: 200mg/body
Alternative magnetic field irradiation on the day of injection and the next day
Resection of injected tumor on the forteenth day of injection
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The case with metastatic measurable tumor in skin or subcutaneous tissue (including lymph node) which is confirmed histologically or cytologically and also the tumor should be larger than the size of designated level.
Refractory to the standard medical therapy (chemotherapy, hormonal therapy, etc) and more than 4 weeks should elapse since the latest treatment.
The case who underwent radiotherapy more than 4 weeks earlier or without indication for radiotherapy
The case with the tumor which can be punctured. The tumor should be located less than 30mm in depth and also amenable to injection.
Performance status(ECOG) 0 to 2.
White blood cell counts >=2,000/uL or neutrophil counts >=1,000/uL
Platelets >=50,000/uL
Serum creatinine <=3mg/dl
AST(GOT)/ALT(GPT) both <=100 IU/L or <=5 X institutional criterion
Having written informed consent.
Key exclusion criteria
The case having intracorporal magnetic substance (cardiac pace maker, dental implant, steel clips, steel bolts)
Pregnant woman, nursing woman
The case having pleural effusion, ascites, pericardial effusion which requires emergent treatment
The case having active infection
The case having double cancer with less than 5 year-disease free period
The case having psychological, familial, social, geographical factors which hamper compliance with the protocol and appropriate follow-up
The case having brain metastases which require emergent treatment for brain hypertension or emergent irradiation
The case who is considered to be inappropriate for this trial by the attending doctor
Target sample size
9
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toyone Kikumori |
Organization
Nagoya University Hospital
Division name
Department of Breast and Endocrine Surgery
Zip code
Address
65 Tsurumaicho, Showaku, Nagoya
TEL
052-744-2251
kikumori@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toyone Kikumori |
Organization
Nagoya University Hospital
Division name
Department of Breast and Endocrine Surgery
Zip code
Address
65 Tsurumaicho, Showaku, Nagoya
TEL
052-744-2251
Homepage URL
kikumori@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Hospital
Institute
Department
Personal name
Funding Source
Organization
Nagoya University Hospital
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 11 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2009 | Year | 10 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 11 | Month | 02 | Day |
Last modified on
| 2013 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003291
